The Use of Doppler to Diagnose Myometrial Masses

Phase 2

• Conditions: Uterine Masses
• Interventions: Other: Three dimensional Power Doppler to the myometrial mass; Other: Uterine artery Doppler

• Registration Number: NCT01833871
• Lead Sponsor: Cairo University

Brief Summary

Colour Doppler sonography has also been evaluated in differentiating adenomyosis from fibroids. Two dimensional color Doppler ultrasound revealed that 87% of adenomyosis cases had vessel distributions different from those found in leiomyoma cases, in addition to a high pulsatility index (PI) .Adenomyotic lesions had randomly scattered vessels or intratumoral signals while leiomyomas usually had peripheral scattered or outer feeding vessels.

Detailed Description

Because it is more sensitive, less angle-dependent, and not susceptible to aliasing , power Doppler Sonography has the potential to detect fluctuations in blood flow , with results superior to those of frequency-based color Doppler sonography, particularly in situations of low-velocity blood flow. Three dimensional power Doppler ultrasonography can be applied to differentiate between uterine adenomyosis and leiomyoma ,and it may reduce the number of false positives by detailed investigations.

Study Timeline

• Study Start: 2013-02
• Status Verified: 2013-04
• Study First Submitted: 2013-04-04
• Study First Submitted QC: 2013-04-15
• Last Update Submitted: 2013-04-15
• Study First Posted: 2013-04-17
• Last Update Posted: 2013-04-17
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• Age between 20 & 60 years.
• Asymptomatic pts which discover the mass accidentally .
• Patients with symptoms like menorrhagia, menometrorrhagia, dysmenorrheal , abdominal masses.
• Patients scheduled for hysterectomy(abdominal/vaginal or Laparoscopic)
• Patients scheduled for myomectomy.

Exclusion Criteria

• Pregnant patients
• Age over 60 or under 20years.
• Conservative management (Non surgical)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
myometrial fibroid/adenomyoma	Uterine artery Doppler	Patients scheduled for myomectomy or hysterectomy with preoperative diagnosis of uterine myoma, adenomyosis or both by ultrasound .Trans-vaginal 3D power Doppler and uterine artery doppler will be done for all participants prior to surgery.
myometrial fibroid/adenomyoma	Three dimensional Power Doppler to the myometrial mass	Patients scheduled for myomectomy or hysterectomy with preoperative diagnosis of uterine myoma, adenomyosis or both by ultrasound .Trans-vaginal 3D power Doppler and uterine artery doppler will be done for all participants prior to surgery.

Primary Outcome Measures

Name	Time	Method
Uterine artery doppler indices in fibroids in relation to adenomyosis	9 months	Uterine artery doppler indices(RI,PI) in fibroids in relation to adenomyosis
Power Doppler Vascular indices	9 months	The ultrasonographic examination will provide data related to lesion size, lesion volume, uterine artery doppler indices and vascular location (location), vascular index (VI), flow index (FI), and vascular-flow index (VFI). The region of interest will include the entire region of the uterine mass. The virtual organ computer aided analysis (VOCAL) software for the analysis of 3D power Doppler histograms will be used with computer algorithms to form indices of blood flow and vascularization. All data will be collected and compared with the post operative histopathology results.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt